APEX BIOLOGIX , LLC

APEX BIOLOGIX , LLC

Address:2561 S 1560 W,W Bountiful,UT,84087,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (JQC) (5) Platelet And Plasma Separator For Bone Graft Handling (ORG) (4) Needle, Aspiration And Injection, Disposable (GAA) (1)

Premarket Exempt

No Yes

Clear

XCELL - B708XCBMASC600 Catalog Number :

Device Description : XCELL Bone Marrow Aspiration System 60ml, convenience kit.

Device Class : 1

Duns Number: 079560357

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

XCELL - B708XCBMC600 Catalog Number :

Device Description : XCELL Bone Marrow Concentrating System XC-BMC-60

Device Class :

Duns Number: 079560357

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

XCELL - B708XCBMC60SUPP0 Catalog Number :

Device Description : XCELL Bone Marrow Concentrating System XC-BMC-60 Supplemental

Device Class : 1

Duns Number: 079560357

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

XCELL - B708XCBMCSC600 Catalog Number :

Device Description : XCELL Bone Marrow Aspirate Concentration System 60ml, convenience kit.

Device Class : 1

Duns Number: 079560357

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

XCELL - B708XCBMSC600 Catalog Number :

Device Description : XCELL Bone Marrow System 60ml, convenience kit Includes 1x XC-BMC-SC-60, Primary XCELL Bone Marrow System 60ml, convenience kit Includes 1x XC-BMC-SC-60, Primary DI B708XCBMCSC600Includes 1x XC-BMA-SC-60, Primary DI B708XCBMASC600

Device Class : 1

Duns Number: 079560357

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

XCELL - B708XCPPX600 Catalog Number : 80-030

Device Description : XCELL Patient Pure X Blood Collection System 60ml

Device Class : 1

Duns Number: 079560357

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

XCELL - B708XCPRP600 Catalog Number :

Device Description : XCELL Platelet Concentrating System XC-PRP-60

Device Class :

Duns Number: 079560357

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

XCELL - B708XCPRP60SUPP0 Catalog Number :

Device Description : XCELL Platelet Concentrating System XC-PRP-60 Supplemental (accessory item)

Device Class :

Duns Number: 079560357

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

XCELL - B708XCPRPBDK10 Catalog Number :

Device Description : Blood Draw Kit for XC-PRP-60 Platelet Concentrating System

Device Class : 2

Duns Number: 079560357

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

XCELL - B708XCRV600 Catalog Number :

Device Description : XCELL Platelet Concentrating System XC-RV-60 RegenVET (Veterinary Applications)

Device Class : 2

Duns Number: 079560357

Premarket Exempt : Yes

Product Code : ORG

Prescription Use : No

Device Count : 1

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